The embodiments described herein may relate to methods and systems for adjusting insulin delivery. Some methods and systems may be configured to adjust insulin delivery to personalize automated insulin delivery for a person with diabetes. Some methods and systems may be configured to adjust insulin delivery to a person with diabetes according to one or more conditions of an insulin delivery device. Some methods and systems may be configured to enable a lock-out mode where adjustment to insulin delivery to personalize automated insulin delivery is restricted.
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1. A system, comprising: an insulin delivery device configured to deliver insulin to a user of the insulin delivery device; and an insulin delivery control unit associated with the insulin delivery device, wherein the insulin delivery control unit is configured to: determining a shelf-life risk score for undelivered insulin within the insulin delivery device; and based on the shelf-life risk score exceeding a threshold, enabling a lock-out mode for locking out automated modification of a baseline basal insulin rate for the user of the insulin delivery device until the insulin delivery device has fresh insulin.
This invention relates to an insulin delivery system designed to manage insulin degradation risks in automated insulin delivery devices. The system includes an insulin delivery device that administers insulin to a user and a control unit that monitors the insulin's shelf-life. The control unit calculates a shelf-life risk score for undelivered insulin within the device, assessing factors like time since manufacture, storage conditions, or other degradation indicators. If the risk score exceeds a predefined threshold, the system activates a lock-out mode, preventing automated adjustments to the user's baseline basal insulin rate. This lock-out remains active until the device is refilled with fresh insulin, ensuring user safety by avoiding potential complications from degraded insulin. The system aims to mitigate risks associated with insulin degradation, which can lead to inaccurate dosing and adverse health effects. The control unit's ability to assess shelf-life risk and enforce restrictions on automated insulin adjustments distinguishes this approach from traditional systems that lack such proactive degradation monitoring.
2. The system of claim 1 , wherein the shelf-life risk score is at least based on an age of the undelivered insulin.
The system monitors and assesses the shelf-life risk of undelivered insulin to ensure product safety and efficacy. The system calculates a shelf-life risk score for insulin that has not yet been delivered to patients, with the score being at least partially determined by the age of the insulin. The system may also consider additional factors such as storage conditions, temperature fluctuations, and handling history to refine the risk assessment. By evaluating these variables, the system helps prevent the distribution of insulin that may have degraded or become unsafe due to prolonged storage or improper handling. The system may generate alerts or recommendations for insulin that exceeds predefined risk thresholds, prompting actions such as disposal, redistribution, or further inspection. This ensures that only insulin within acceptable quality parameters reaches patients, reducing the risk of adverse effects from degraded medication. The system integrates with inventory management and logistics processes to track insulin from manufacturing to delivery, maintaining a comprehensive record of its condition throughout the supply chain.
3. The system of claim 1 , wherein determining a shelf-life risk score for undelivered insulin within the insulin delivery device comprises receiving a shelf-life risk score from a diabetes management system.
The system relates to diabetes management, specifically monitoring and assessing the shelf-life risk of undelivered insulin within an insulin delivery device. The problem addressed is ensuring the safety and efficacy of insulin by tracking its remaining usable lifespan, as insulin can degrade over time, potentially leading to reduced effectiveness or adverse health effects if used beyond its shelf life. The system includes a diabetes management system that calculates a shelf-life risk score for undelivered insulin based on factors such as storage conditions, expiration dates, and usage patterns. This score is then transmitted to the insulin delivery device, which uses it to determine whether the insulin is still viable for administration. The system may also include a user interface to alert the user if the insulin is at risk of being expired or degraded, prompting timely replacement or disposal. Additionally, the system may log historical data on insulin usage and shelf-life risk to improve future predictions and recommendations. The overall goal is to enhance patient safety by ensuring that only viable insulin is administered, reducing the risk of ineffective treatment or complications.
4. The system of claim 1 , wherein the insulin delivery control unit controls the insulin delivery device to: deliver insulin at a first point in time according to a first insulin delivery action of a first series of insulin delivery actions of a first insulin delivery profile, the first series of insulin delivery actions including at least one action that includes delivering insulin at a rate larger than the baseline basal insulin rate; and deliver insulin at a second point in time according to a first insulin delivery action of a second series of insulin delivery actions of a second insulin delivery profile, the second series of insulin delivery actions including delivering insulin at the rate larger than the baseline basal insulin rate, wherein the shelf-life risk score is further based on a number of times insulin is delivered at the rate larger than the baseline basal insulin rate exceeding a threshold.
This invention relates to an insulin delivery system designed to optimize insulin administration while monitoring shelf-life risk. The system includes an insulin delivery device and a control unit that manages insulin delivery based on predefined profiles. The control unit executes a first insulin delivery profile at a first time, delivering insulin at a rate higher than the baseline basal rate as part of a series of actions. Similarly, it executes a second insulin delivery profile at a second time, also delivering insulin at a rate exceeding the baseline basal rate. The system assesses shelf-life risk by tracking the frequency of these higher-rate deliveries. If the number of such deliveries surpasses a predefined threshold, the risk score is adjusted accordingly. This approach ensures precise insulin dosing while maintaining awareness of potential degradation risks associated with frequent high-rate deliveries. The system dynamically balances therapeutic effectiveness with long-term insulin stability, improving patient safety and treatment reliability.
5. The system of claim 1 , further comprising a diabetes management system associated with the insulin delivery device and configured to track undelivered insulin within the insulin delivery device.
This invention relates to a diabetes management system integrated with an insulin delivery device, addressing the challenge of tracking undelivered insulin to improve patient safety and treatment accuracy. The system monitors insulin within the delivery device to detect and record instances where insulin is not properly administered, such as due to device malfunctions, user errors, or other interruptions. By tracking undelivered insulin, the system provides real-time alerts and historical data to healthcare providers and patients, enabling timely corrective actions and adjustments to treatment plans. The diabetes management system may include sensors, data logging capabilities, and communication interfaces to ensure continuous monitoring and reporting. This feature enhances the reliability of insulin therapy by identifying discrepancies between prescribed and delivered doses, reducing the risk of hypoglycemia or hyperglycemia. The system may also integrate with other diabetes management tools, such as glucose monitoring devices, to provide a comprehensive overview of a patient's metabolic control. The invention aims to improve diabetes care by ensuring accurate insulin delivery and proactive management of potential dosing errors.
6. The system of claim 5 , wherein tracking undelivered insulin within the insulin delivery device comprises tracking an age of undelivered insulin.
The system is designed for managing insulin delivery in medical devices, specifically addressing the challenge of tracking and ensuring the quality of undelivered insulin. Insulin, a critical medication for diabetes management, can degrade over time, making it essential to monitor its age to prevent the use of expired or compromised insulin. The system includes a tracking mechanism that monitors the age of undelivered insulin within the device. This involves recording the time since the insulin was loaded into the device or since it was last used, ensuring that only insulin within its effective lifespan is administered. The tracking mechanism may also include alerts or notifications to indicate when insulin is nearing or has exceeded its usable age, prompting replacement or disposal. By continuously monitoring the age of undelivered insulin, the system enhances patient safety by preventing the administration of degraded insulin, which could lead to ineffective treatment or adverse health effects. The system integrates with the broader insulin delivery device, which may include pumps or automated injection systems, to provide real-time tracking and management of insulin quality. This ensures that patients receive accurate and timely insulin doses while minimizing the risk of using expired medication.
7. The system of claim 5 , wherein the diabetes management system associated with the insulin delivery device is configured to track insulin delivery actions of the insulin delivery device.
A diabetes management system integrates with an insulin delivery device to monitor and manage insulin administration. The system tracks insulin delivery actions, including dosage amounts, timing, and frequency, to optimize diabetes treatment. It may also analyze user data such as blood glucose levels, dietary intake, and physical activity to provide personalized recommendations. The system ensures accurate insulin dosing, reduces the risk of hypoglycemia or hyperglycemia, and improves overall diabetes management. By continuously monitoring insulin delivery, the system helps users and healthcare providers make informed decisions, enhancing treatment efficacy and patient safety. The integration of tracking capabilities ensures real-time adjustments and proactive interventions, supporting better glycemic control.
8. The system of claim 7 , wherein the diabetes management system associated with the insulin delivery device is configured to determine a frequency of an insulin delivery action of the tracked insulin delivery actions, wherein the insulin delivery action comprises delivering a dose of insulin that exceeds a threshold.
This invention relates to a diabetes management system integrated with an insulin delivery device, addressing the challenge of optimizing insulin dosing to improve glycemic control. The system tracks insulin delivery actions, including doses that exceed a predefined threshold, and analyzes their frequency to assess patient behavior and treatment efficacy. By monitoring high-dose events, the system can identify patterns that may indicate suboptimal insulin management, such as frequent overcorrections or improper dosing. The system may then adjust recommendations or alert healthcare providers to intervene, enhancing safety and treatment adherence. The insulin delivery device, which may be a pump or pen, communicates with the management system to log delivery actions, including time, dose amount, and context. The system processes this data to derive actionable insights, such as dose frequency trends, to support personalized diabetes care. This approach helps prevent hypoglycemia or hyperglycemia by detecting and addressing excessive insulin administration, improving overall diabetes management.
9. The system of claim 8 , wherein the threshold is a multiple or a fraction of the baseline basal insulin rate.
The invention relates to a medical system for managing insulin delivery in diabetes treatment, specifically addressing the challenge of optimizing basal insulin dosing to prevent hypoglycemia while maintaining glycemic control. The system includes a controller that adjusts insulin delivery based on a threshold value derived from a baseline basal insulin rate. The threshold is dynamically set as either a multiple or a fraction of this baseline rate, allowing for personalized and adaptive insulin adjustments. This approach ensures that insulin delivery remains within safe and effective limits, reducing the risk of hypoglycemia while maintaining therapeutic efficacy. The system may also incorporate feedback mechanisms, such as continuous glucose monitoring, to further refine insulin dosing in real-time. By dynamically adjusting the threshold relative to the baseline rate, the system provides a more responsive and patient-specific approach to insulin management compared to fixed-threshold systems. This innovation is particularly useful for automated insulin delivery systems, where precise and adaptive control is critical for patient safety and treatment effectiveness.
10. A method comprising: determining a shelf-life risk score for undelivered insulin within an insulin delivery device; and based on the shelf-life risk score exceeding a threshold, locking out automated modification of a baseline basal insulin rate for a user of the insulin delivery device until the insulin delivery device has fresh insulin.
This invention relates to insulin delivery devices and addresses the problem of ensuring safe insulin administration by preventing the use of degraded insulin. The method involves assessing the shelf-life risk of undelivered insulin within the device by calculating a shelf-life risk score. This score evaluates factors such as insulin age, storage conditions, and environmental exposure to determine whether the insulin may have degraded beyond safe usage limits. If the score exceeds a predefined threshold, indicating a high risk of degraded insulin, the device automatically locks out any automated adjustments to the user's baseline basal insulin rate. This lockout remains in effect until the device is refilled with fresh insulin, ensuring that the user does not receive potentially ineffective or harmful insulin doses. The method helps prevent complications from degraded insulin while maintaining safety in automated insulin delivery systems.
11. The method of claim 10 , wherein the shelf-life risk score is at least based on an age of the undelivered insulin.
Technical Summary: This invention relates to a system for assessing and managing the shelf-life risk of undelivered insulin, particularly in automated dispensing or delivery systems. The problem addressed is the degradation of insulin over time, which can compromise its efficacy and safety if not properly monitored and managed. The method involves calculating a shelf-life risk score for undelivered insulin, which is at least based on the age of the insulin. The age of the insulin is determined by tracking the time elapsed since its manufacture or initial dispensing. The shelf-life risk score quantifies the likelihood that the insulin has degraded beyond acceptable limits, helping to ensure patient safety and product efficacy. The system may also consider additional factors in determining the shelf-life risk score, such as storage conditions (e.g., temperature, humidity), usage history, and environmental exposure. By continuously monitoring these factors, the system can provide real-time risk assessments and trigger alerts or actions when the insulin is deemed unsafe for use. The method may further include steps to mitigate risks, such as automatically removing expired or high-risk insulin from circulation, notifying healthcare providers or patients, or recommending alternative treatments. This proactive approach helps prevent the administration of degraded insulin, reducing the risk of adverse health outcomes. The invention is particularly useful in automated insulin delivery systems, such as those used in hospitals, pharmacies, or home care settings, where ensuring the quality and safety of insulin is critical.
12. The method of claim 10 , wherein determining the shelf-life risk score for undelivered insulin within the insulin delivery device comprises receiving a shelf-life risk score from a diabetes management system.
The invention relates to systems and methods for managing insulin delivery and monitoring shelf-life risk in insulin delivery devices. The technology addresses the problem of ensuring the safety and efficacy of undelivered insulin within such devices by assessing its remaining shelf-life. A diabetes management system calculates a shelf-life risk score for the insulin, which is then used to determine whether the insulin is still viable for use. This score is based on factors such as storage conditions, expiration dates, and usage history. The system may also provide alerts or recommendations to users or healthcare providers if the insulin is at risk of degradation. By integrating this risk assessment into the diabetes management system, the invention helps prevent the use of compromised insulin, thereby improving patient safety and treatment effectiveness. The method ensures that only insulin meeting quality standards is administered, reducing the risk of adverse effects from degraded medication.
13. The method of claim 10 , further comprising: delivering insulin at a first point in time according to a first insulin delivery action of a first series of insulin delivery actions of a first insulin delivery profile, the first series of insulin delivery actions including at least one action that includes delivering insulin at a rate larger than the baseline basal insulin rate; and delivering insulin at a second point in time according to a first insulin delivery action of a second series of insulin delivery actions of a second insulin delivery profile, the second series of insulin delivery actions including delivering insulin at the rate larger than the baseline basal insulin rate; wherein the shelf-life risk score is further based on a number of times insulin is delivered at the rate larger than the baseline basal insulin rate exceeding a threshold.
This invention relates to an insulin delivery system that adjusts insulin administration based on a shelf-life risk score to optimize both glycemic control and insulin stability. The system monitors insulin delivery actions, particularly those involving rates higher than a baseline basal rate, to assess potential degradation risks. The method involves delivering insulin at a first time according to a first profile, where the profile includes at least one action with an elevated delivery rate compared to the baseline. Similarly, insulin is delivered at a second time according to a second profile, also featuring elevated rates. The shelf-life risk score is influenced by the frequency of these elevated-rate deliveries exceeding a predefined threshold. By tracking these occurrences, the system can mitigate degradation risks while maintaining therapeutic effectiveness. The approach ensures that insulin remains stable while adapting to patient needs, balancing immediate glycemic control with long-term insulin viability. This method is particularly useful in automated insulin delivery systems where repeated high-rate deliveries could compromise insulin integrity over time.
14. The method of claim 10 , wherein locking out automated modification of a baseline basal insulin rate prevents modification of the baseline basal insulin rate upwards while allowing automated modification of the baseline basal insulin rate downwards.
This invention relates to insulin delivery systems, specifically methods for managing automated adjustments to baseline basal insulin rates in diabetes management devices. The problem addressed is the need to prevent unintended increases in baseline insulin delivery while still allowing necessary reductions to avoid hypoglycemia. The method involves a diabetes management system that includes an insulin pump and a controller. The controller monitors glucose levels and adjusts the baseline basal insulin rate based on predefined criteria. A key feature is the ability to lock out automated upward modifications of the baseline rate while permitting downward adjustments. This ensures that the system cannot automatically increase the baseline rate beyond a user-defined or clinically safe threshold, reducing the risk of insulin stacking or hyperglycemia. However, the system can still automatically reduce the baseline rate if glucose levels fall too low, preventing hypoglycemia. The method may also include additional safety features, such as user overrides, manual adjustments, and alerts to notify the user of automated changes. The system may also log adjustment events for review by healthcare providers. This approach balances automation with safety, ensuring that insulin delivery remains within safe limits while still allowing necessary corrections.
15. The method of claim 10 , further comprising generating a message that the shelf-life risk score has exceeded the threshold.
A system and method for monitoring and assessing shelf-life risk of perishable items, such as food products, pharmaceuticals, or other time-sensitive goods, to prevent spoilage or degradation. The system tracks environmental conditions, such as temperature, humidity, and exposure to light, that may affect the shelf life of stored items. Sensors continuously collect data on these conditions, which is then processed to calculate a shelf-life risk score based on predefined thresholds for acceptable storage conditions. If the risk score exceeds a predetermined threshold, indicating a high likelihood of spoilage or degradation, the system generates an alert message to notify users or stakeholders. This alert may be sent via email, SMS, or another communication channel to ensure timely intervention. The system may also log historical data for analysis, allowing for trend identification and optimization of storage conditions. The method ensures that perishable items remain within safe and effective storage parameters, reducing waste and improving product quality.
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January 12, 2018
December 10, 2019
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